Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnormal stresses placed on the recently repaired fractures. Historically, diabetics have been kept non weight bearing for extended periods of time, which has its own functional and cardiovascular issues. The purpose of the study is to determine if a protocol of immediate weight bearing with a hindfoot offloading brace after surgically corrected ankle fracture in a diabetic patient will maintain adequate motion, have no difference in complications when compared to regular non-immediate weight bearing protocols, and lead to good outcome scores and patient satisfaction scores
详细描述
Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnormal stresses placed on the recently repaired fractures. Historically, diabetics have been kept non weight bearing for extended periods of time, which has its own functional and cardiovascular issues. The purpose of the study is to determine if a protocol of immediate weight bearing with a hindfoot offloading brace after surgically corrected ankle fracture in a diabetic patient will maintain adequate motion, have no difference in complications when compared to regular non-immediate weight bearing protocols, and lead to good outcome scores and patient satisfaction scores
Patients will be recruited from the trauma and foot & ankle service lines. Patients who have experienced an isolated ankle fracture (excluding pilon fracture) and will undergo operative fixation within 3 weeks of injury will be approached for consent. Patients will then be screened based on the inclusion and exclusion criteria. Up to 25 patients will be enrolled
The following protocol will be applied after enrollment
- Pre-operatively
a. Hemoglobin A1c will also be collected from each patient if it has not been performed within the last 30 days. 2. Post-operatively a. Post-surgery i. Standard of Care:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 and ove
- •Positive for diabetes
- •Positive monofilament test
- •Isolated ankle fracture (non-pilon) and undergoing operative intervention within 3 weeks of fracture
- •Weight less than 275 (124kg)
- •Can tolerate and comply with brace
- •No signs of pre-existing charcot arthroplasty or ankle deformity
排除标准
- •Pregnant patients
- •No signs of diabetes complicated by neuropathy
- •Non-operative ankle fractures
- •Multiple extremity injury
- •Cannot follow post-operative protocol
- •Chronic ankle fractures receiving surgery beyond 3 weeks of injury
研究组 & 干预措施
Hindfoot Offloading Braces / Immediate Weight-bearing
Diabetic patients over 18 years of age who sustained an isolated (non-pilon) ankle fracture will undergo ORIF of the ankle fracture within 3 weeks of the event
干预措施: Postoperative protocol (Immediate weight bearing) (Other)
No Hindfoot Offloading Braces / Delayed Weight-Bearing
Diabetic patients over 18 years of age who sustained an isolated (non-pilon) ankle fracture will undergo ORIF of the ankle fracture within 3 weeks of the event
干预措施: Postoperative Protocol (Delayed Weight Bearing) (Other)
结局指标
主要结局
Adverse Events
时间窗: 12 months
Adverse Events by type over time, severity, seriousness, and relatedness. AEs will be tabulated and summarized as counts and percentages. AEs will also be cross-tabulated according to: 1. Severity; 2. Unanticipated Adverse Device Effect (UADE) 3. Seriousness (Serious Adverse Event (SAE), Non-serious AE); 4. Device-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related); 5. Procedure-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related).
次要结局
- AAOS Foot and Ankle Score(12 Months)
- PROMIS Score(12 Months)
研究者
Kyle Schweser MD
Assistant Professor Orthopaedic Trauma/Foot and Ankle
University of Missouri-Columbia
